• custom-made medical devices
• 3D printing
• absorbable scaffold
• pectus excavatum
• class III implantable devices

This thesis work aims to describe all the fundamental steps required to design, manufacture, and place on the market BellaSeno custom-made absorbable scaffolds to correct pectus excavatum deformity.
The workflow generated within this thesis work covers several crucial topics: the regulatory requirements for class III custom-made medical devices, the design of accurate scaffolds in a CAD software starting from patients’ DICOM, the anonymization process required to collect and share health data, the design verification process, the 3D printing process, and the final shipping of the scaffolds for surgical implantations.
Original Templates, Protocols, Checklists, and Flowcharts have been designed in this thesis work to facilitate BellaSeno GmbH to design and deliver high-quality Pectus Scaffolds within the expected time.